MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97800

Device Problems Electromagnetic Interference (1194); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that patient contacted us because they were experiencing pain in the implant location and indicated that they had lifted something hard two days prior.They said they had already turned off the therapy, but they wanted us to turn it off from here since they were in pain.They left a message with their doctor this morning but have not received a response.I stated that they needed to seek medical guidance, which we could not supply.They then mentioned that they activate the mri mode and were feeling better, but it appears that the implant needs to be removed.The patient was redirected to their healthcare provider to further address the issue.Unable to ask info about hcp patient were feeling pain and discomfort, they were referred to get urgent medical assistance.Additional information was received from a healthcare professional (hcp).The hcp reported that the device was affected by the heavy lifting.The pain was not cause by or related to the device, therapy, or implant procedure.Patient requested device to be removed on (b)(6) 2024.The issue was resolved.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They reported that they were implanted with a faulty device.They stated two weeks after the surgery, they had a mri, and they used the mri mode.When they deactivated the mri mode, the screen of the programmer turn in a big ball and they started to have a extreme pain in her back for hours, after two weeks with the implant on thursday they started to have the pain, and on monday they had a surgery to remove it.They stated they would speak with a lawyer about a product liability case.Patient stated that we need to call them back if we would like that they don't start a court case.Patient stated that they already spoke with a manufacturing representative (rep).The circumstances that led to the reported issue were unknown.The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19060940
• MDR Text Key: 339609874
• Report Number: 3004209178-2024-08654
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/08/2024; 04/15/2024; 04/16/2024
• Supplement Dates FDA Received: 04/08/2024; 04/16/2024; 05/06/2024
• Date Device Manufactured: 12/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 100 KG